Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers

Официальное название

A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers

Обзор

This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).

Вмешательства

• Препарат TQB2928 injection + Almonertinib Mesilate Tablets
  TQB2928 is a recombinant fully humanized Immunoglobulin G4 (IgG4) monoclonal antibody that can promote tumor cell phagocytosis by macrophages and exert anti-tumor effects. Almonertinib Mesilate Tablets is a third generation of EGFR-TKI targeting drug.

Первичные конечные точки

• Phase II recommended combination doses (RP2CD) [Срок оценки: Baseline up to 24 months]
• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Time to Progression [Срок оценки: Up to 2 years]

Вторичные конечные точки (7)

• Elimination half-life (t1/2) [Срок оценки: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)]
• Area under the plasma concentration-time curve (AUC0-last) [Срок оценки: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)]
• Apparent Plasma Clearance (CL) [Срок оценки: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)]
• Apparent volume of distribution(Vz) [Срок оценки: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)]
• Steady-state trough concentration (Css-min) [Срок оценки: Cycle 1 Day1: in 0.5 hour pre-dose and immediately after dose, 2, 6, 24 hours; Day1 and Day15 of Cycle 1, Cycle 2 Day1: in 0.5 hour pre-dose and immediately after dose; Day1 on Cycle 3, Cycle 4, Cycle 5: in 0.5 hour pre-dose (each cycle is 3 weeks)]
• Immunogenicity: anti-drug antibody (ADA) [Срок оценки: From the time of informed consent signed through 90 days after the last dose]
• Adverse Events (AE) rate [Срок оценки: From date of the first dose until the date of 30 days after last dose or new anti-tumor treatment, whichever came first]

Критерии участия

Критерии включения

• Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；
• Locally advanced or metastatic NSCLC diagnosed by histology or cytology
• The major organs are functioning well；
• Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；
• Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.

Критерии исключения

• Current concomitant presence of other malignancies within 5 years prior to the first dose;
• Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;
• Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;
• Long-term unhealed wounds or fractures;
• Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;
• A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
• Subjects with any severe and/or uncontrolled disease;
• History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;
• Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06585059 · TQB2928-Ib-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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